Method development and validation for quantitative determination of methadone enantiomers in human plasma by liquid chromatography/tandem mass spectrometry1

Liang, Hongru; Foltz, Rodger L.; Mei, Meng; Bennett, Patrick

doi:10.1016/j.jchromb.2004.03.059

Cited by 56 publications

(42 citation statements)

References 27 publications

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“…Procedures found in the literature especially focus not only on the morphine-based opioids buprenorphine (BUP), 19 -27 codeine (COD) and morphine (MOR) 28 -38 itself but also on opioids like FEN, 39 -41 hydromorphone (HYD) 42 -44 or methadone (MET). 45 LC-MS methods for analysis of the other opioids of interest like oxycodone (OC), 31,46,47 oxymorphone (OM), 46 piritramide (PIR), 48,49 tilidine (TIL) and tramadol (TRA), 50 -52 and especially assays for the simultaneous determination of different opioids 53 are rarely described. Patients under palliative care often receive combinations of various opioids, e.g.…”

Section: Introductionmentioning

confidence: 99%

An automated and fully validated LC‐MS/MS procedure for the simultaneous determination of 11 opioids used in palliative care, with 5 of their metabolites

Mußhoff¹,

Trafkowski²,

Kuepper³

et al. 2006

J. Mass Spectrom.

113

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A fully validated liquid chromatographic procedure coupled with electrospray ionization-tandem mass spectrometry (LC-ESI-MS/MS) is presented for quantitative determination of the opioids buprenorphine, codeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, piritramide, tilidine, and tramadol together with their metabolites bisnortilidine, morphine-glucuronides, norfentanyl, and nortilidine in blood plasma after an automatically performed solid-phase extraction (SPE). Separation was achieved in 35 min on a Phenomenex C12 MAX-RP column (4 microm, 150 x 2 mm) using a gradient of ammonium formiate buffer (pH 3.5) and acetonitrile. The validation data were within the required limits. The assay was successfully applied to authentic plasma samples, allowing confirmation of the diagnosis of overdose situations as well as monitoring of patients' compliance, especially in patients under palliative care.

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Section: Introductionmentioning

confidence: 99%

An automated and fully validated LC‐MS/MS procedure for the simultaneous determination of 11 opioids used in palliative care, with 5 of their metabolites

Mußhoff¹,

Trafkowski²,

Kuepper³

et al. 2006

J. Mass Spectrom.

113

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“…11 Several analytical methods for the detection of multiple opiod drugs in different biological matrices such as whole blood, 11 oral fluids, 12 urine, 13 meconium, 14,15 plasma, 16 hair, 17,18 skin, 19 sweat, 20 and placenta 21 have been reported using LC-MS/MS, LC/MS, GC/MS, UPLC-MS/MS, and LC-APCI-MS/MS.…”

Section: 10mentioning

confidence: 99%

“…[11][12][13][14][15][16][17][18][19][20][21] According to the LODs from the literature shown in Table 4, our assay using the described Bond Elut Certify method of choice allows the detection and quantification of 6-MAM, morphine, codeine, fentanyl, heroin, and methadone in human whole blood and plasma at subtherapeutic and toxic levels. In equal matrices we have obtained similar LODs.…”

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confidence: 99%

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Development and Validation of a Solid-Phase Extraction Gas Chromatography-Mass Spectrometry Method for the Simultaneous Quantification of Opioid Drugs in Human Whole Blood and Plasma

Bravo

González

Benites

2011

J. Chil. Chem. Soc.

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A rapid, selective, sensitive, and specific method is presented to simultaneously quantify morphine, 6-monoacetylmorphine (6-MAM), codeine, heroin, fentanyl, and methadone in human whole blood and plasma. The drugs were extracted with phosphate buffer at pH 6, followed by solid-phase extraction (SPE) and quantification by GC/MS with electron impact ionization using helium as carrier gas. Quantification was performed based on nalorphine as internal standard (IS). The specificity, linearity, intra-and inter-assay precision and accuracy, and extraction recovery were fully evaluated. The limits of detection (LODs) were 0.40 -7.63 ng/mL for whole blood and 0.80 -32.00 ng/mL for plasma. The method is fast, simple, and accurate, with the sensitivity and specificity required in forensic and clinical toxicology.

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“…Another useful approach of assessing matrix effect is postcolumn infusion of an analyte into the MS detector. While the analyte is continuously infused through a tee to the mobile phase eluent, the extracted blank matrix is injected by an autosampler onto the analytical column [130][131][132][133][134][135][136]. The instrument configu-ration for post-column infusion experiment is shown in (Fig.…”

Section: Matrix Effects and Recoverymentioning

confidence: 99%

Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods

Zhou¹,

Song²,

Tang³

et al. 2005

CPA

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Swift growth in the use of LC-MS/MS for the analysis of drugs in biological matrices has been compelled by the need for timely and high-quality data at many stages in drug discovery and development process: from high throughput screening of drug candidates and rapid data generation for pre-clinical studies to almost 'real-time' analysis of clinical samples. Prompt and rational method development, validation, and transfer play a pivotal role in achieving the goals of "faster, better, and cheaper" for pharmacokinetic studies since this could easily account for more than 50% of the time and labor resources for a moderate-sized project. Strategy for rational method development, validation and transfer has been largely kept as institutional knowledge but rarely appeared in literature. In this review article, strategies for developing and validating robust high throughput LC-MS/MS methods will be critically reviewed and discussed. Automated sample preparation, fast chromatography, minimization of matrix effects, and strategy of narrowing the gap between validation and incurred sample analysis are just a few topics covered in this review. Other interesting approaches for improving method efficiency and ruggedness such as direct injection SPE and liquid/liquid extracts as well as multiplexing of LC columns will also be discussed. Potential pitfalls during method development and validation are pointed out. At the end, the question "how fast is fast enough and how fast is too fast?" will be answered after considering all aspects of the method development and validation.

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Method development and validation for quantitative determination of methadone enantiomers in human plasma by liquid chromatography/tandem mass spectrometry1

Cited by 56 publications

References 27 publications

An automated and fully validated LC‐MS/MS procedure for the simultaneous determination of 11 opioids used in palliative care, with 5 of their metabolites

An automated and fully validated LC‐MS/MS procedure for the simultaneous determination of 11 opioids used in palliative care, with 5 of their metabolites

Development and Validation of a Solid-Phase Extraction Gas Chromatography-Mass Spectrometry Method for the Simultaneous Quantification of Opioid Drugs in Human Whole Blood and Plasma

Critical Review of Development, Validation, and Transfer for High Throughput Bioanalytical LC-MS/MS Methods

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